Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis - Full Text View

Purpose

A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.

Condition	Intervention	Phase
Mastitis	Biological: Lactobacillus salivarius HN6 Biological: Lactobacillus reuteri CR20 Biological: Lactobacillus fermentum LC40 Drug: Beta-lactam antibiotic	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Breast Diseases Breast Feeding

Drug Information available for: Amoxicillin Amoxicillin sodium Lactobacillus

U.S. FDA Resources

Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:

Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	July 2008
Study Completion Date:	May 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Probiotic 1 Women receiving Lactobacillus salivarius HN6	Biological: Lactobacillus salivarius HN6 9 log colony-forming units, capsules, daily, four weeks
Experimental: Probiotic 2 Women receiving Lactobacillus reuteri CR20	Biological: Lactobacillus reuteri CR20 9 log colony-forming units, capsules, daily, four weeks
Experimental: Probiotic 3 Women receiving Lactobacillus fermentum LC40	Biological: Lactobacillus fermentum LC40 9 log colony-forming units, capsules, daily, four weeks
Active Comparator: beta-lactam The evolution of the women ascribed to the other three arms will be compared with that of 100 women suffering lactational mastitis that will follow a conventional antibiotic treatment as prescribed by the pediatrician/gynecologist	Drug: Beta-lactam antibiotic Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis) Other Name: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine

Eligibility

Ages Eligible for Study:	19 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of mastitis
Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk
Milk leukocyte count higher 6 log10/mL
Must be able to provide a milk sample without the aid of a milk pump

Exclusion Criteria:

Mammary abscesses
Any kind of parallel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716183

Locations

Spain
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Spain, 28040

Sponsors and Collaborators

Universidad Complutense de Madrid

More Information

Publications:

Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez JM. Oral administration of lactobacilli strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Jun 6; [Epub ahead of print]

Martín R, Olivares M, Marín ML, Fernández L, Xaus J, Rodríguez JM. Probiotic potential of 3 Lactobacilli strains isolated from breast milk. J Hum Lact. 2005 Feb;21(1):8-17; quiz 18-21, 41.

Martín R, Langa S, Reviriego C, Jimínez E, Marín ML, Xaus J, Fernández L, Rodríguez JM. Human milk is a source of lactic acid bacteria for the infant gut. J Pediatr. 2003 Dec;143(6):754-8.

Martín R, Heilig GH, Zoetendal EG, Smidt H, Rodríguez JM. Diversity of the Lactobacillus group in breast milk and vagina of healthy women and potential role in the colonization of the infant gut. J Appl Microbiol. 2007 Dec;103(6):2638-44.

Delgado S, Arroyo R, Martín R, Rodríguez JM. PCR-DGGE assessment of the bacterial diversity of breast milk in women with lactational infectious mastitis. BMC Infect Dis. 2008 Apr 18;8:51.

Martín R, Jiménez E, Olivares M, Marín ML, Fernández L, Xaus J, Rodríguez JM. Lactobacillus salivarius CECT 5713, a potential probiotic strain isolated from infant feces and breast milk of a mother-child pair. Int J Food Microbiol. 2006 Oct 15;112(1):35-43. Epub 2006 Jul 14.

Olivares M, Díaz-Ropero MP, Martín R, Rodríguez JM, Xaus J. Antimicrobial potential of four Lactobacillus strains isolated from breast milk. J Appl Microbiol. 2006 Jul;101(1):72-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez JM. Treatment of Infectious Mastitis during Lactation: Antibiotics versus Oral Administration of Lactobacilli Isolated from Breast Milk. Clin Infect Dis. 2010 May 10; [Epub ahead of print]

Responsible Party:	Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:	NCT00716183 History of Changes
Other Study ID Numbers:	Promast08
Study First Received:	July 14, 2008
Last Updated:	May 22, 2009
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Complutense de Madrid:

mastitis
Staphylococcus
Streptococcus
lactation
breastfeeding

Additional relevant MeSH terms:

Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Amoxicillin
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid

Cloxacillin
Lactams
Beta-Lactams
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013